# K240454: RESPONDER® Polysaccharide Hemostat

- Pathway: 510(k) (Special)
- Applicant: Starch Medical, Inc.
- Decided: Mar 15, 2024 after 29 days
- Product code: QSY (Hemostatic Wound Dressing Without Thrombin Or Other Biologics)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K002550 (2000). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220525: RESPONDER Polysaccharide Hemostat, Starch Medical, Inc. (2023) Summary page 4.

## Indications for use
RESPONDER® Polysaccharide Hemostat OTC is indicated for the local management of bleeding such as lacerations, minor cuts and abrasions.

Source page: https://510kreport.com/device/K240454
Methodology: https://510kreport.com/methodology